Molecular PROfiling in Early Clinical Trials- North East (PROSPECT-NE)
Research type
Research Study
Full title
Molecular PROfiling in Early Clinical Trials- North East (PROSPECT-NE)
IRAS ID
216629
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
The development of new drugs for patients with cancer is increasingly aimed at targeting the genetic abnormalities that have arisen within the tumour. Patients who have exhausted all standard treatment options for their cancer may be referred to the Sir Bobby Robson Early Clinical Trials Unit (SBRU) for consideration of early clinical trials, investigating the safe dose, side effect profile and effectiveness of new anti-cancer drugs The tumour molecular abnormalities present in patients presenting for consideration of early clinical trials in the North East of England is not known. We would like to know this information to help prioritise which drugs should b e investigated in Newcastle. This study will assess the molecular profile of the tumours of patients referred to SBRU on left over samples from the biopsy or surgery where their cancer was diagnosed.
Unfortunately patients may wait several months whilst awaiting a slot on a suitable early clinical trial. Some of these patients may become less well to the point where they are not able to safely enrol on an early clinical trial ,or stay on treatment long enough to see if it will work. We want to see if we can in the future use blood tests that estimate the amount of cancer a patient has, and the impact on their body to better monitor patients whilst they are waiting for clinical trials.Summary of Results
The study’s primary aim was to identify the differences in genetic make-up in cancers and identify mutations in tumours that may be targeted by newly developed treatments in early phase clinical trials, for patients who had exhausted all standard treatment options. However, the technologies for identifying genetic abnormalities was rapidly evolving and the technologies used in this study was superseded by other studies, which give a quicker turnaround of results and therefore offered quicker potential treatments for patients. Hence, the study underwent early termination with a total of 136 out of the originally proposed 600 participants being recruited. There were no implications for patients recruited to the study in terminating the study early as patients who may have been potential participants for this study could consent to genetic testing of their cancer, from a blood sample, through testing offered by 'Foundation Medicine'.
Results from the study showed there are significant differences in the prevalence of some mutations compared to mutations identified internationally by the Cancer Genome Atlas (TCGA) project that characterized mutations in over 11000 cancer samples. There was a significantly higher prevalence of the mutations in the gene called EGFR in lung cancer, the gene called RB1 in breast cancer and in multiple mutations in prostate cancer. Understanding local prevalence of cancer mutations and trial availability could increase enrolment onto matched early phase clinical trials The study also collected data to investigate whether changes in tumour development, and evidence of frailty in patents, over time predicts their response to therapy (both in terms of shrinkage of tumour and treatment toxicities experienced) and also survival. Data collected included quality of life questionnaires, grip strength, ability of patients to perform ordinary tasks and carry out daily activities and blood tests to analyse blood markers of tumour development and frailty. This data is currently undergoing analysis in preparation for publication.
133 of the 136 participants recruited agreed for their remaining biological samples to be stored in the Newcastle Biobank for future ethically approved research studies.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0208
Date of REC Opinion
26 Jul 2017
REC opinion
Further Information Favourable Opinion